BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q PAIN BUSTER

    MDR report key: 644739 · Received November 4, 2005

    Report

    Report Number
    2026095-2005-00084
    Event Type
    Death
    Date Received
    November 4, 2005
    Date of Event
    October 12, 2005
    Report Date
    November 1, 2005
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I-FLOW WAS INFORMED BY AN ORTHOPEDIC SURGEON IN 2005 THAT A PT HE HAD PERFORMED A TOTAL KNEE REPAIR ON THE PREVIOUS DAY HAD DIED THIS MORNING FROM CAUSES THAT ARE CURRENTLY UNDER INVESTIGATION. THE SURGEON INDICATED THAT HE DID NOT SUSPECT THE PUMP IN THIS INCIDENT; HE REFERRED THE I-FLOW SALES REP TO THE ANESTHESIOLOGIST THAT WAS INVOLVED IN THIS INCIDENT FOR FURTHER INFO. THE ANESTHESIOLOGIST INDICATED TO THE SALES REPPRESENTATIVE THAT HIS INITIAL ASSESSMENT WAS THAT IT WAS A COMBINATION OF DRUGS (I.E. MORPHINE AND PHENERGAN) THAT MAY HAVE BEEN THE CAUSE, BUT HE DID NOT SUSPECT THE PUMP. HE STATED THAT THE PT WAS HAVING AN UPSET STOMACH AS THE RESULT OF THE MORPHINE SO THEY STARTED HER ON PHENERGAN, WHICH ACCORDING TO THE ANESTHESIOLOGIST, MAY HAVE PRODUCED TOO MUCH CARBON DIOXIDE IN THE BLOOD. FURTHERMORE, THE ANESTHESIOLOGIST SUSPECTS THAT THIS RESULTED IN THE PT BECOMING TOO SEDATED AND WAS NOT BEING MONITORED CLOSE ENOUGH BY THE HOSP STAFF. TO DATE, THE AUTOPSY NOR THE TOXICOLOGY REPORT HAS BEEN RELEASED. ACCORDING TO THE HOSP AND SURGEONS DIRECTLY RELATED TO THIS INCIDENT, THE ON-Q PUMP IS CURRENTLY NOT A SUSPECT DEVICE IN THIS INCIDENT AND WILL BE RELEASED FOR HOSP RE-ENTRY ONCE THE PUMP IS CLEARED BY THE TOXICOLOGY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN BUSTER INFUSION PUMP MEB I-FLOW CORP. CB004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death